Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT05095935
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2021-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medtronic Signia SDR Product Surveillance Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-23', 'releaseDate': '2025-12-05'}], 'estimatedResultsFirstSubmitDate': '2025-12-05'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 430}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2021-10-25', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of intraoperative hemostatic intervention', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of repeat hospital admission for primary procedure-related complications', 'timeFrame': '30 days'}, {'measure': 'Intraoperative assessments: Assessment of staple line integrity using a five-point Likert scale', 'timeFrame': '30 days', 'description': 'Range from 1 (no bleeding) to 5 (significant bleeding requiring intervention)'}, {'measure': 'Intraoperative assessments: Incidence of staple line bleeding (measured as > 50cc)', 'timeFrame': '30 days'}, {'measure': 'Intraoperative assessments: Additional intervention(s) to treat staple line failure', 'timeFrame': '30 days', 'description': 'Additional interoperative interventions to treat staple line failure (Applying additional stapler reloads, Applying compression greater than what is considered typical, Over-sewing with suture, Placing clips, Use of energy, Use of seatbelt, Other)'}, {'measure': 'Post-operative assessments: Additional intervention(s) to treat staple-line failure', 'timeFrame': '30 days', 'description': 'Additional postoperative interventions to treat staple line failure (Applying additional stapler reloads, Applying compression greater than what is considered typical, Over-sewing with suture, Placing clips, Use of energy, Use of seatbelt, Other)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Minimally Invasive Surgical Procedures', 'Surgical Procedures, Operative']}, 'descriptionModule': {'briefSummary': 'The purpose of the registry is to confirm the safety and performance of the Signia™ Small Diameter Reload (SDR) when used in surgical procedures in a real-world setting in patients receiving surgery for indicated thoracic, abdominal, and pediatric applications, intraoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing surgical procedures during which the Signia Small Diameter Reload is being used for transection of the arteries and veins meeting the cohort criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements\n* Patient has, or is intended to receive or be treated with, an eligible Medtronic product\n* Patient is consented within the enrollment window of the therapy received, as applicable\n\nExclusion Criteria:\n\n* Patient who is, or is expected to be, inaccessible for follow-up\n* Patient is excluded by local law\n* Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the PSR results'}, 'identificationModule': {'nctId': 'NCT05095935', 'briefTitle': 'Medtronic Signia SDR Product Surveillance Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic'}, 'officialTitle': 'Medtronic Signia Small Diameter Reload Product Surveillance Registry', 'orgStudyIdInfo': {'id': 'Surgical PSR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Thoracic Adult', 'description': 'Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.', 'interventionNames': ['Other: N/A observational registry']}, {'label': 'Abdominal Adult', 'description': 'Use of Signia SDR for the transection of renal arteries and veins in adult patients.', 'interventionNames': ['Other: N/A observational registry']}, {'label': 'Abdominal Pediatric', 'description': 'Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.', 'interventionNames': ['Other: N/A observational registry']}], 'interventions': [{'name': 'N/A observational registry', 'type': 'OTHER', 'description': 'N/A observational registry', 'armGroupLabels': ['Abdominal Adult', 'Abdominal Pediatric', 'Thoracic Adult']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Health System', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health Systems', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Falk Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78249', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22401', 'city': 'Fredericksburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Mary Washington Hopital', 'geoPoint': {'lat': 38.30318, 'lon': -77.46054}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-12-05', 'type': 'RELEASE'}, {'date': '2025-12-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Medtronic'}}}}